Respiratory system and mask interface background

ABSTRACT

A mask interface for a respiratory mask, in which the mask interface comprises a resilient mask housing at least partially formed from a textile and being configured to deform under pressure from an external force, such as when being pressed against a pillow, and to substantially return to its original shape either automatically or by manipulation by a user.

BACKGROUND Technical Field

The present disclosure generally relates to a respiratory system for thedelivery of respiratory therapy to a user. More particularly, thepresent disclosure relates to a respiratory mask and a mask interfacefor use in a respiratory system.

Description of the Related Art

Respiratory masks and mask interfaces are used to provide respiratorytherapy to the airways of a person suffering from any of a number ofrespiratory illnesses or conditions. Such therapies may include but arenot limited to continuous positive airway pressure (CPAP) therapy andnon-invasive ventilation (NIV) therapy.

CPAP therapy can be used to treat obstructive sleep apnoea (OSA), acondition in which a user's airway intermittently collapses, duringsleep, preventing the user from breathing for a period of time. Thecessation of breathing, or apnoea, results in the user awakening.Repetitive and frequent apnoeas may result in the user rarely achievinga full and restorative night's sleep.

CPAP therapy involves the delivery of a supply of continuous positiveair pressure to the airway of the user via a respiratory mask. Thecontinuous positive pressure acts as a splint within the user's airway,which secures the airway in an open position such that the user'sbreathing and sleep are not interrupted.

Respiratory masks typically comprise a mask interface and a headgear,wherein the mask interface is configured to deliver the supply ofcontinuous positive air pressure to the user's airway via a seal orcushion that forms an airtight seal in or around the user's nose and/ormouth. The mask interface includes a seal or cushion that is held inplace on the user's face by the headgear. In order to maintain anairtight seal the headgear should provide support to the mask interfacesuch that it is held in a stable position relative to the user's faceduring use. Respiratory masks are available in a range of stylesincluding full-face, nasal, direct nasal and oral masks, which create anairtight seal with the nose and/or mouth. Such respiratory masks mayalso be used to deliver NIV and other breathing treatment therapies.

Traditional mask interfaces may present several disadvantages. Onedisadvantage relates to the substantially rigid structure of the maskinterface. Because most mask interfaces are substantially rigid instructure, users who wear respiratory masks with these mask interfacesoften find that their ability to change sleeping positions isrestricted, due to the rigid mask interface coming into contact withtheir pillow or other bedding. For example, a user may not be able tocomfortably lie on their side when wearing a traditional full-face maskinterface, as a result of the substantially rigid mask interfacecontacting the pillow. Contact between the mask interface and the pillowmay hold the user's head at an uncomfortable angle; cause increasedpressure points that lead to discomfort and in some cases skin damage;or cause the seal between the mask interface and the user's face to bebroken, resulting in air leaks and loss of therapy.

Another disadvantage of traditional mask interfaces is that most CPAPmask interfaces on the market currently have a clinical appearance. Suchan appearance may not be appealing for users to wear in a bedroomsetting and may discourage users from wearing their mask and receivingeffective breathing treatment therapy.

Some fully textile/fabric mask interfaces are available on the market.These textile masks may help avoid the sleep position difficulties thatcan arise with a rigid mask interface and may be designed to look lessclinical in appearance. However, the overall lack of structure inexisting textile mask interfaces can make them more difficult to use.The lack of structure also means that these types of mask interfaces areprone to collapsing on themselves when not in use. When a mask is in acollapsed configuration, such as after being placed in storage, theshape of the mask distorts, which can make it difficult for a user tounderstand how to reshape and apply the mask for a correct fit.

BRIEF SUMMARY

The systems and devices described herein have innovative aspects, nosingle one of which is indispensable or solely responsible for theirdesirable attributes. Without limiting the scope of the claims, some ofthe advantageous features will now be summarized.

In broad terms, the invention relates to a respiratory mask interfacehaving a traditional silicone seal in combination with a resilienthousing that is capable of deforming when it comes into contact with asufficiently deforming external force (such as pressure from pressingagainst a pillow for example) and returning to its original form eitherautomatically or by manipulation by a user. The invention also relatesto a respiratory mask comprising such a compliant and resilient maskinterface. In addition, the invention relates to a respiratory systemfor delivering breathing gas to a user and comprising a respiratory maskor mask interface according to the invention.

In a first aspect, the invention provides a mask interface fordelivering breathing gas to a user, wherein the mask interfacecomprises:

a seal comprising a gas inlet configured to seal against the user'sface; and

a 3-dimensional mask housing directly or indirectly attached to theseal,

wherein the mask housing comprises at least one gas inlet and wherein atleast a portion of the mask housing is formed from fabric and comprisesa first flexible, resilient support structure configured to at leastpartially retain the 3-dimensional shape of the mask housing

Preferably, the seal is formed of silicone. The seal may also comprise arolling bridge, wherein the seal comprises an upper portion configuredto roll over onto an outer surface of the seal and/or the mask housingand/or the frame of the mask interface, as described in WO2012/140514,which is incorporated herein by reference. To assist with the rolling ofthe upper portion, the upper portion can have a varying thickness or avarying stiffness. To reduce the prevalence of ballooning in the upperportion and to provide enhanced structure in the upper portion, areinforcing component or components, such as a band, can be positionedalong at least a portion of the upper portion. The band extends along atleast a portion of the upper portion of the seal. The upper portion ofthe mask comprises an apex when viewed from the front. The apex can bedefined as a tip, a top or an angular summit of the mask seal, whichapex is positioned in proximity to the nose of the user when in use.

The band and the stiffer region (e.g., a region of thicker crosssection) adjacent to the region of reduced stiffness help to initiaterolling of the region of reduced stiffness. In other words, a controlledbuckling of the region of reduced stiffness occurs with the assistanceof the adjacent stiffer portions. In some configurations, the region ofreduced stiffness is bounded by a first boundary and a second boundary,wherein the first boundary and the second boundary have an increasedstiffness relative, to the region of reduced stiffness. In theillustrated configuration, for example, the first boundary is defined byor alongside the hand. The second boundary can be defined by oralongside an edge of the mask housing. In some configurations, thesecond boundary can be defined along a portion of the seal positionedbetween the mask housing and the region of reduced stiffness,

As the upper portion of the seal is displaced about a hinge axis, theroll increases in size. In other words, as the first boundary initiallymoves toward the second boundary, a roll is formed in the seal. As thefirst boundary continues to move toward the second boundary, the roll,continues to increase in site. Thus, the roll defined in the upperportion starts at nothing and progressively increases duringdisplacement of the upper portion as shown in dashed lines. Preferably,the rolling between the first boundary and the second boundary creates asingle bend or inflection between the first boundary and the secondboundary.

In an embodiment, the mask interface comprises a first upper portioncomprising a first wall and a second wall converging to an apex, theapex being positioned in use in proximity to the nose of a user; a lowerportion being connected to and positioned below the first upper portion.The mask interface also comprises a face contacting flange defined atleast in part by the first upper portion and the lower portion and ahinge axis (H) extending laterally across the mask interface, whereinthe first upper portion is positioned vertically higher than the hingeaxis (H). A first boundary extends along at least a portion of the firstwall and along at least a portion of the second wall, the first boundarycomprising a first end and a second end, both ends being spaced awayfrom the hinge axis (H) toward the apex. The mask interface alsocomprises a radius R defined between the hinge axis (H) and the apex anda second upper portion positioned distally from the first upper portionin a direction away from the face contacting flange. The second upperportion comprises an arc length defined along an upper extremity of asurface of the second upper portion, the arc length forming a secondboundary. A radius r is defined between the hinge axis (H) and anuppermost point of the arc length. The radius R is different than theradius r. At least a portion of a first outer surface of the first upperportion is configured to roll so as to overlie or underlie at least aportion of a second outer surface of the second upper portion when thefirst boundary is moved toward the second boundary.

In an embodiment, the mask interface comprises a first upper portioncomprising a first wall and a second wall converging to an apex, theapex being positioned in use in proximity to the nose of a user. A lowerportion is connected to and positioned below the first upper portion. Aface contacting flange is defined at least in part by the first upperportion and the lower portion. A first boundary extends along at least aportion of the first wall and along at least a portion of the secondwall. A second upper portion is positioned distally from the first upperportion in a direction away from the face contacting flange, the secondupper portion comprising an arc length defined along an upper extremityof a surface of the second upper portion. The arc length forms a secondboundary. The first upper portion further comprises a region of reducedstiffness positioned between the first and second boundaries, whereinthe region of reduced stiffness is configured to roll to allow pivotingof at least a portion of the first upper portion relative to the secondupper portion when the first boundary is moved toward the secondboundary. The region of reduced stiffness is bounded by the first andsecond boundaries and the first and second boundaries having anincreased stiffness relative to the region of reduced stiffness.

In an embodiment, the mask interface comprises a first upper portioncomprising a first wall and a second wall converging to an apex. Theapex is positioned in use in proximity to the nose of a user. A hingeaxis (H) extends laterally across the mask interface and the first upperportion is positioned vertically higher than the hinge axis. A bandextends along at least a portion of the first wall and along at least aportion of the second wall, the band comprising a first end and a secondend, both ends being spaced away from the hinge axis (H) toward theapex. The band forms a first boundary. A radius R is defined between thehinge axis (H) and the apex. A second upper portion is positioneddistally from the first upper portion in a direction away from a facecontacting surface. The second upper portion comprises an arc lengthdefined along an upper extremity of the surface of the second upperportion, the arc length forming a second boundary. A radius r is definedbetween the hinge axis (H) and an uppermost point of the arc length. Theradius R is different than the radius r. At least a portion of a firstouter surface of the first upper portion is configured to roll so as tooverlie or underlie at least a portion of a second outer surface of thesecond upper portion when the first boundary is moved toward the secondboundary. In an embodiment, the seal comprises a seal of flexiblematerial, the seal having a first side and a second side, the first sideof the seal being shaped to approximately match the contours of a user'sface and in use substantially seal against a user's face, the secondside attached to a clip. The clip comprises a bridging portion spanningoutwards from the perimeter or periphery of the mask housing to space atleast a portion of the second side of the seal outwards from theperimeter or periphery of the mask housing. The mask interface alsocomprises an inner cushion located between the bridging portion of theclip and the first side of the seal. The clip comprises a channel in thebridging portion. A first side of the inner cushion in use supports thefirst side of the seal, and a second side of the inner cushion isreceived in the channel.

In an embodiment, the seal comprises a first wall and a second wallconverging to an apex, the apex being positioned in use in proximity tothe nose of a user. The seal also comprises a face contacting flange anda hinge axis (H) extending laterally across the patient interface. Anupper portion of the mask seal is positioned vertically higher than thehinge axis (H). A band extends along at least a portion of the firstwall and along at least a portion of the second wall, the bandcomprising a first end and a second end, both ends being spaced awayfrom the hinge axis (H) toward the apex. The band forms a firstboundary. A radius R is defined between the hinge axis (H) and the apex.A mask seal clip is positioned distally from the mask seal in adirection away from the face contacting flange. An arc length is definedalong an upper extremity of the surface of the mask seal clip. The arclength forms a second boundary, and a radius r is defined between thehinge axis (H) and an uppermost point of the arc length. The radius R isdifferent than the radius r. At least a portion of a first outer surfaceof the mask seal is configured to roll so as to overlie or underlie atleast a portion of a second outer surface of the mask seal clip when thefirst boundary is moved toward the second boundary

In one form, the mask housing is fully formed from a textile. Forexample, the housing may comprise a single sheet of fabric comprising atleast one seam or fold to form the 3-dimensional shape of the maskhousing. Alternatively, the housing may comprise multiple pieces offabric joined together by one or more seams to form a 3-dimensionalshape.

Preferably, the fabric is airtight.

In one form, an airtight coating or layer is provided on an internalsurface of at least the fabric portion of the mask housing.

In one form, the respiratory mask further comprises a frame comprising agas inlet and being configured to attach to the seal and mask housing,so that the gas inlet of the frame substantially forms a fluid flow pathwith the gas inlets of the seal and mask housing.

Optionally, the frame forms a ring-like structure. In one form, theframe is located at or near an outer peripheral edge of the mask housingand is configured to provide a substantially rigid connection by whichthe mask housing may be connected to the seal.

Preferably, the frame is made from a polycarbonate, or other rigid orsemi-rigid plastic.

In one form, the frame is over-moulded to the mask housing and the sealis over-moulded to the frame.

In one form, the frame comprises a support structure comprising one ormore resilient support members that extend from the frame to support the3-dimensional shape of the mask housing. Optionally, the support membersare formed from the same material as the frame. In one form, the supportmembers are co-moulded with the mask housing.

In one form, the first support structure of the mask housing isconfigured to at least partially deform under a sufficient deformingexternal force and to substantially return to its original shape afterthe force is removed. Preferably, the first support structure isconfigured to substantially return to its original shape automaticallyafter the force is removed. Alternatively, the first support structureis configured to substantially return to its original shape undermanipulation by a user after the deforming force is removed.

In one form, the first support structure is located on an interiorsurface of the mask housing.

In one form, the first support structure is integrally formed with themask housing.

In another form, the first support structure is located on an exteriorsurface of the mask housing and is attached to the mask housing.

In one form, the first support structure comprises a resilient supportlayer applied to interior and/or exterior surfaces of the fabric portionof the mask housing to increase the thickness of one or more regions ofthe housing. The support layer may be applied near outer edges of themask housing and/or along sides of the mask housing to increase thethickness of these regions. Preferably, the support layer comprises anelastomer. For example, the support layer may comprise a vinyl orsilicone lining.

In one form, the first support structure comprises a skeleton structurecomprising a plurality of resilient support members. Preferably, thestructural support comprises a plurality of resilient or semi-resilientfilaments. The filaments may be plastic filaments or metal wires.Optionally, the support members are located on an interior surface ofthe mask housing to form an internal skeleton support structure. Inanother form, the support members are integrally formed with at leastone fabric portion of the mask housing. In yet another form, the supportmembers are located on an exterior surface of the mask housing and areattached to the mask housing to provide structural support.

In another form, the first support structure comprises a ridge that isprovided in a fabric portion of the mask housing. The ridge may compriseat least one fold line or seam along which the mask housing willnaturally fold when squashed. Optionally, the ridge extends from asubstantially central point at a central region of the mask housing to asubstantially central point near an upper edge of the mask housing.

In one form, the mask housing is formed from multiple pieces of fabricjoined by one or more seams, and wherein each seam is configured to forma ridge that provides structural support to the mask housing.

Optionally, the mask interface is configured for use with a CPAPmachine.

Also disclosed herein is a mask interface for delivering breathing gasto a user. The respiratory mask comprises a seal. The seal comprises agas inlet and is configured to seal against the user's face, and a maskhousing directly or indirectly attached to the seal. The mask housingcomprises at least one gas inlet. At least a portion of the mask housingmay be formed from a fabric. The mask housing is configured to be of asubstantially compliant 3-dimensional shape so as to deform under asufficient external force without breaking the seal between the maskinterface and the user's face and to be substantially resilient so that,after the external force is removed, the mask housing can at leastpartially revert to its original 3-dimensional shape either with orwithout user assistance.

In a second aspect, the invention provides a respiratory mask comprisinga mask interface according to the first aspect of the invention andfurther comprising headgear for holding the mask interface against auser's face. Optionally, the headgear comprises a pair of collapsiblegas delivery conduits configured to deliver gas from a gas source to thegas inlet(s) of the mask housing. The gas delivery conduits may be atleast partially formed from a textile. Optionally, the gas deliveryconduits are configured to connect to a gas delivery tube of arespiratory system at the top of the headgear.

In a third aspect, the invention provides a respiratory systemcomprising a respiratory mask according to the second aspect of theinvention and a gas delivery tube comprising a first end configured toconnect to the mask interface and a second end configured to connect toa gas source. Optionally, the respiratory system is configured for usewith a CPAP machine.

Embodiments of systems, components and methods of assembly andmanufacture will now be described with reference to the accompanyingfigures, wherein like numerals refer to like or similar elementsthroughout. Although several embodiments, examples and illustrations aredisclosed below, it will be understood by those of ordinary skill in theart that the inventions described herein extends beyond the specificallydisclosed embodiments, examples and illustrations, and can include otheruses of the inventions and obvious modifications and equivalentsthereof. The terminology used in the description presented herein is notintended to be interpreted in any limited or restrictive manner simplybecause it is being used in conjunction with a detailed description ofcertain specific embodiments of the inventions. In addition, embodimentsof the inventions can comprise several novel features and no singlefeature is solely responsible for its desirable attributes or isessential to practicing the inventions herein described.

Throughout this specification and claims, the term “textile layer” isintended to mean a layer of the mask housing that at least partiallycomprises a textile/fabric.

Terms such as “top”, “bottom’, “upper”, “lower”, “front”, “back”,“left”, “right”, “rear”, and “side” describe the orientation and/orlocation of portions of the components or elements within a consistentbut arbitrary frame of reference which is made clear by reference to thetext and the associated drawings describing the components or elementsunder discussion. Moreover, terms such as “first”, “second”, “third”,and so on may be used to describe separate components. Such terminologymay include the words specifically mentioned above, derivatives thereof,and words of similar import.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to.”

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers orcomponents are herein incorporated as if individually set forth.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred forms of the invention will now be described in relation tothe accompanying drawings in which:

FIG. 1 is a perspective view of one form of mask interface according tothe present invention;

FIG. 2 is a side view of the mask interface of FIG. 1 ;

FIG. 3 is a front view of the mask interface of FIG. 1 ;

FIG. 4 is a perspective top view of the mask interface of FIG. 1 in acollapsed or deformed state;

FIG. 5 is a rear view of one form of mask interface showing a supportstructure for a mask housing that includes a substantially resilientlayer of material;

FIG. 6 is a partial cut-away side view of one form of mask showing a gasinlet at the side of the mask;

FIG. 7 is a partial cut-away side perspective view of another form ofmask showing a support structure for a mask housing that includessupport members in the form of filaments;

FIG. 8 is a rear view of the mask of FIG. 7 ; and

FIG. 9 is a partial cut-away side perspective view of another form ofmask having a frame and a support structure comprising support fingersthat extend from the frame to support the 3-dimensional shape of themask housing.

DETAILED DESCRIPTION

Referring to FIGS. 1 to 9 , the invention relates to a mask interface1000, a respiratory mask 2000 comprising such a mask interface 1000, anda respiratory system for the delivery of breathing gas to a user. Therespiratory mask 2000 is configured to be worn by a user to deliverbreathing gas to the user. The respiratory mask 2000 comprises a maskinterface 1000, comprising a seal 100 and mask housing 200, and aheadgear assembly 300. Optionally, the mask interface 1000 alsocomprises a frame 400 that supports the seal 100 and mask housing 200.The respiratory mask 2000 may be a full face mask, a nasal mask or apillows mask.

The mask interface 1000 may comprise a connection system to attach tothe headgear assembly 300. The headgear assembly 300 is used to hold themask interface 1000 to the user's face. The headgear is typicallyattached to the mask interface 1000 and wraps around the rear of theuser's head to seal the mask interface 1000 against the user's face.Various forms of connection systems may be used to attach the headgearassembly 300 to the mask interface 1000. Similarly, the mask interface1000 may be coupled to at least one and possibly multiple differenttypes of headgear assemblies 300.

The seal 100 of the mask interface may comprise a front or distalsurface and a rear surface or proximal surface. The rear surface of theseal 100 may be configured to substantially seal against a user's faceduring use. The seal 100 may be configured to fit over a user's mouth,nose, or both for sealing around and/or underneath a user's mouth and/ornose.

In one form, as shown particularly in FIGS. 1 to 5 , the seal 100 formsa mask cushion configured to contact a user's face and to form a sealbetween the user's face and the mask interface 1000. For example, theseal 100 may be configured to substantially seal around a user's noseand mouth. Optionally, the seal 100 is resiliently deformable to fit andseal against a range of facial geometries. In one form, the seal 100 maycomprise a rolling bridge 110 that fits over a user's nose and providesthe seal 100 with a degree of customization to better fit and seal witha user's face. The seal 100 may be formed of any suitable material, suchas silicone for example.

The seal 100 may comprise a gas inlet opening for receiving a breathinggas.

The mask housing 200 may be at least partially formed, and preferablyfully formed, from a fabric/textile formed into a 3-dimensional shape.The fabric mask housing 200 may be substantially deformable under asufficient external force. The mask housing 200 may also be configuredto resume its original 3-dimensional shape either automatically afterremoval of the external force, or by manipulation of the mask housing200 by a user. For example, the fabric mask housing 200 may comprise afirst support structure/structural support 250 that is substantiallyflexible, to allow the mask housing to at least partially deform under asufficient external force, and that is substantially resilient, to allowthe mask housing 200 to substantially revert to its original3-dimensional shape after removal of the external force.

In embodiments, such as those shown in FIGS. 6 and 7 , where the maskinterface 1000 comprises a frame 400, the seal 100 is configured to beattached to the frame 400. Optionally, the seal 100 comprises one ormore attachment features to help locate and/or attach the seal 100 tothe frame 400. In one form, the seal 100 may be over-moulded to theframe 400.

The frame 400 may be configured to provide additional structure to theseal 100. For example, the frame 400 may comprise a substantiallyresilient structure to prevent the seal 100 from collapsingunintentionally. The frame 400 may also provide additional structure tothe deformable fabric mask housing 200. For example, the frame 400 mayprovide a support structure/structural support 450 to the mask housing200. Where the mask housing 200 includes a first support structure 250,the frame 400 may optionally provide a second support structure.Alternatively, the frame 400 may provide the only support structure forthe mask housing 200. In yet another form, only the mask housing 200 maycomprise a support structure to support its 3-dimensional shape.

The frame 400 may comprise a body comprising a first surface or frontsurface and a substantially opposing second surface or rear surface. Thebody of the frame 400 may comprise an outer edge that defines the outerperiphery of the frame 400. The frame 400 also comprises a gas inletthat may be located substantially centrally within the frame. The gasinlet is defined by an inner edge of the frame 400 and may be relativelylarge so that the body of the frame 400 forms a substantially thinboundary structure around the gas inlet. For example, the frame 400 maycomprise a ring-like support structure for supporting the seal 100 andmask housing 200. The ring-like support structure of the frame 400 maybe of any suitable regular or irregular shape, such as a substantiallycircular or elliptical shape, an oval shape, a triangular shape or aquadrilateral shape for example.

The frame 400 and seal 100 may be configured to be attached together sothat the gas inlet openings of each part substantially align with eachother. In one form, the frame 400 may comprise a gas inlet openingdefined by a substantially continuous edge provided by a seal flangeprojecting from the rear surface of the frame 400. The gas inlet opening120 of the seal 100 may comprise a substantially continuous lipconfigured to attach to the seal flange of the frame 400.

The frame 400 is typically located at or near an outer peripheral edgeof the mask housing 200 and is configured to provide a substantiallyrigid connection by which the mask housing 200 may be connected to theseal 100. For this reason, the frame 400 is preferably made from amaterial that has greater rigidity than the seal 100 and mask housing200 so that the frame 400 is capable of providing sufficient support tothe seal 100 and housing 200. In one form, the frame 400 is made frompolycarbonate, but in alternative forms, the frame may be made from anysuitable rigid or semi-rigid material, such as nylon, polypropylene,other rigid or semi-rigid plastics, or even metal. In anotherembodiment, the frame 400 may comprise a thickened rim of material, suchas silicone, on the outer perimeter of the seal 100. The resilientconfiguration of the frame 400 may provide the mask interface 1000 witha support structure to support the seal and/or mask housing.

In one form, the frame may be over-moulded to the mask housing 200. Inanother form, the mask interface 1000 may comprise a clipping structurethat connects the seal 100, frame 400 and housing 200 together. However,it should be appreciated that any other suitable attachment system maybe used to attach the seal 100, housing 200 and frame 400 together.

The mask housing 200 may be configured to provide at least one gas inlet210 that substantially forms a fluid flow path with the gas inlets ofthe seal 100 and frame 400 to provide the mask interface 1000 with a gasinlet. Optionally, the mask housing 200 comprises a pair of gas inlets210 configured to form a fluid flow path with the gas inlets of the seal100 and frame 400 and to connect to a pair of gas supply conduits 350(350 a and 350 b). The gas inlet(s) 210 may be located at one or bothsides of the mask housing 200, as shown in FIG. 6 , or at the front ofthe mask housing 200, as shown in FIG. 7 .

The mask housing 200 may be at least partially or entirely formed offabric and may be configured to provide an appearance of softness andcomfort. The fabric may be any suitable form of woven or knittedtextile/fabric and may comprise natural fibres (such as cotton, wool, orbamboo fibres, for example), synthetic fibres (such as nylon,polypropylene, or acrylic fibres, for example) or a combination of both.Preferably, at least an outer surface of the mask housing 200 comprisesa soft, non-scratchy fabric.

The mask housing 200 may be configured to provide a flexible butsubstantially resilient enclosure that directly or indirectly attachesto the seal 100 to form an airtight breathing chamber.

To ensure that the mask housing 200 is airtight, the fabric used in thehousing 200 should be airtight or should be used in combination with anairtight material, such as vinyl for example. In one form, at least thefabric portion of an inner surface of the housing 200 may comprise alayer or coating of airtight material. In another form, the fabricportion of the housing 200 may be impregnated with a substance such asplastic or resin that provides the fabric/textile with airtightproperties.

In one form, the mask housing 200 may be configured to be sufficientlyflexible to at least partially collapse under an external force, such aswhen pressed against a pillow for example. FIG. 4 illustrates one formof respiratory mask 2000 in which the mask housing 200 has beendeformed. In this embodiment, the collapsing mask housing 200 reducesmask pull when the mask interface 1000 presses against the pillow or bedso that a user may sleep comfortably on his or her side while wearingthe respiratory mask 2000. The mask housing 200 may also be configuredso that the seal against a user's face is substantially retained evenwhen the mask housing 200 partially collapses or when the user wears themask interface 1000 while sleeping on his or her side.

The mask housing 200 of the present invention may be configured to besubstantially resilient. For example, the mask housing 200 may beconfigured to have a shape memory so that a user can manipulate acollapsed mask to substantially return the mask to its originalnon-collapsed 3-dimensional shape. In some forms, the mask housing 200may be configured to provide a shape memory that biases the mask housing200 to a non-collapsed 3-dimensional shape. In this embodiment, afterremoving the external force that has caused the mask housing 200 tocollapse, the mask housing 200 may automatically return to orsubstantially return to its non-collapsed shape without interferencefrom a user.

In one form, the mask housing 200 may be configured to be sufficientlyresilient to return to a substantially non-collapsed 3-dimensional shapeby using a first support structure 250. The first support structure 250may interact with at least the fabric portion of the mask housing 200 toencourage the housing 200 to return to its original shape after thehousing 200 has been deformed under an external force.

In one form, as shown in FIGS. 5 and 6 , the mask housing 200 maycomprise the support structure 250 in the form of a support layer 251configured to provide additional structure to the mask interface 1000.In one form, the support layer 251 may be a resilient layer comprisingan elastomer, such as silicone for example, that is applied to theinterior and/or exterior of at least one fabric portion 205 of the maskhousing 200. The resilient support layer may be applied to one or moreregions of the mask housing 200 to increase the thickness of thoseregions. In one form, as shown in FIG. 6 , the support layer 251 may bean interior lining or coating. For example, the support layer 251 may bea vinyl or silicone lining. The interior lining may be configured to bethicker in areas of the mask housing 200 where additional structure isrequired. For example, the interior lining may be thicker near outeredges of the mask housing 200 and/or along sides of the mask housing200.

In another form, the mask housing 200 may comprise a fabric/textileportion, such as a fabric/textile layer, and a first support structure250 in the form of a skeleton structure comprising a plurality ofresilient support members 252 configured to at least partially supportthe 3-dimensional shape of the fabric portion. In this arrangement, themask housing 200 may be sufficiently flexible to at least partiallydeform when a user wearing the mask sleeps on his or her side and mayalso be sufficiently resilient to substantially return to its originalshape either automatically or by manipulation by a user.

The support members 252 may or may not interconnect with each other. Byinterconnecting the support members 252, a more resilient supportstructure 250 is provided to the mask housing. The geometry of thesupport members 252 may provide flexibility to allow the support members252 to deform together with the mask housing 200.

In one form, as shown in FIG. 7 , the support members 252 compriseresilient or semi-resilient filaments, such as plastic filaments ormetal wires for example. The filaments 252 a may be configured to atleast partially deform under force, such as under an external pressureforce that occurs when the mask housing 200 presses against a pillow.The resilient nature of the filaments 252 a means that the filaments 252a may be configured to automatically return to an original desired shapeor to return to the original shape under manipulation by a user.

In one form, as shown in FIG. 8 , the support members 252 may be locatedon an interior surface of the fabric/textile layer of the mask housingto form an internal skeleton support structure 250 that may or may notbe connected to the fabric layer. In another form, the support members252 may be integrally formed with a fabric layer to form the maskhousing 200. For example, the support members 252 may comprise a plasticor silicone material and may be co-moulded with fabric to form the maskhousing 200. In yet another form, the support members 252 may be locatedon an exterior surface of the mask housing 200 and may be attached tothe mask housing 200 to provide structural support.

In another form, as shown in FIG. 9 , the support members 252 comprisefingers 252 b that extend from the frame 400 of the mask interface 1000,forming a support structure 450 of the frame 400. Optionally, thefingers 252 b may be made from the same material as the frame 400. Inone form, the fingers 252 b are integral with the mask housing 200. Forexample, the fingers 252 b may be co-moulded with the mask housing 200.

In another form, as shown in FIG. 3 , the mask housing 200 may comprisea support structure 250 in the form of a ridge 252 c that is provided ina fabric/textile portion of the housing 200. The ridge 252 c may form afold line along which the mask housing 200 will naturally fold whensquashed. The ridge 252 c may be configured to provide the mask housing200 with sufficient support to hold a three-dimensional shape and to atleast partially collapse under force. The ridge 252 c may be a fold(such as a pleat for example) or seam formed in the mask housing 200.Optionally, the ridge 252 c extends from a substantially central pointat a central region of the mask housing 200 to a substantially centralpoint near an upper edge of the mask housing 200. In this configuration,the ridge 252 c may form a substantially vertical line.

In one form, as shown best in FIG. 3 , the mask housing 200 is formedfrom a single sheet of fabric/textile that is formed into a3-dimensional shape by at least one seam that forms a ridge 252 c alongwhich the housing will naturally fold when squashed. The seam or ridge252 c forms a support structure 250 that provides additional structureand some resilience to the housing 200. In another form, the3-dimensional shape of the resilient mask housing 200 may be formed frommultiple pieces of fabric joined by one or more seams to form one ormore fold lines or ridges 252 c to form a support structure. In both ofthese configurations, the seams in the fabric layer may provide the maskhousing with an element of structural resilience and may help a user tomanipulate a collapsed mask interface 1000 so as to return the maskinterface 1000 to a substantially non-collapsed state.

An additional or alternative way of configuring the mask housing 200 toprovide a shape memory may be by selecting a fabric that encourages themask housing 200 to at least partially collapse under force and tosubstantially return to a non-collapsed form either automatically or bymanipulation from a user.

In one form, the mask interface 1000 may comprise a seal 100, asdescribed above, and a mask housing 200, as described above. In otherwords, it is not essential for the mask interface 1000 to comprise aframe 400. In this form, the seal 100 and mask housing 200 may beconfigured to connect to each other by any suitable attachment system.For example, the seal 100 and housing 200 may comprise complimentaryattachment features, such as male and female attachment members or aclipping structure, as described above. In another form, the seal 100and housing 200 may be adhered together or the seal 100 may beover-moulded to the housing 200. In yet another form, the seal 100 maycomprise a lip or channel that engages with an edge of the mask housing200 to attach the housing 200 to the seal 100.

The respiratory mask 2000 is configured to connect to a supply ofbreathable gas to deliver breathable gas to a user via the maskinterface 1000. In one form, the respiratory mask 2000 comprises a pairof collapsible gas supply conduits 350 that form part of a headgearassembly 300. The gas supply conduits 350 may be formed of any suitablematerial. For example, the gas supply conduits 350 may be at leastpartially or fully formed from fabric. In one form, the gas supplyconduits 350 are formed from an airtight fabric/textile material. Thegas supply conduits 350 are configured to extend across each side of auser's face, in use, as shown in FIGS. 1 to 3 .

Optionally, the gas supply conduits 350 are configured to connect to agas delivery tube of a respiratory system via a connection 500 at thetop of the headgear assembly 300 so that in use, the connection 500 willbe located at the top of the user's head. In this configuration, theeffect of hose pull (from the gas delivery tube pulling on therespiratory mask) is reduced. In another form, the gas supply conduits350 may be connected to the mask housing via traditional directconnections or elbow connections for example.

In one form, the respiratory mask 2000 or mask interface 1000 may beconfigured for use with a CPAP machine.

In one form, the respiratory mask 2000 may form part of a respiratorysystem that also comprises a gas delivery tube comprising a first endconfigured to connect to the mask interface 1000 and a second endconfigured to connect to a gas source.

The respiratory mask 2000, mask interface 1000 and respiratory system ofthe invention may provide several advantages. For example, the resilientmask housing 200 of the mask interface 1000 may be sufficientlycompliant to suit the user's sleeping position without compromisingsealing performance

By using a silicone seal 100 with the mask interface 1000, asubstantially reliable sealing structure may be provided that is alsoeasy to fit.

In some forms, the fabric/component of the mask housing 200 may make therespiratory mask 2000 feel and/or look soft and warm to touch, which mayprovide the respiratory mask 2000 with a less clinical appearance andmay be more comforting to a user.

1-34. (canceled)
 35. A mask interface configured to deliver breathinggas to a user, the mask interface comprising: a seal comprising a gasinlet configured to seal against a face of the user; and a 3-dimensionalmask housing directly or indirectly attached to the seal, wherein the3-dimensional mask housing comprises: at least one gas inlet, at leastone fabric portion, and a flexible, resilient support structureconfigured to at least partially retain a shape of the 3-dimensionalmask housing, the flexible, resilient support structure comprising aplurality of support members.
 36. The mask interface of claim 35,wherein the plurality of support members is integrally formed with theat least one fabric portion.
 37. The mask interface of claim 35, whereineach of the plurality of support members interconnects with each other.38. The mask interface of claim 35, wherein the flexible, resilientsupport structure comprises a skeleton structure comprising theplurality of support members.
 39. The mask interface of claim 35,wherein each of the plurality of support members comprises a first endand a second end, wherein a width of the first end is greater than awidth of the second end.
 40. The mask interface of claim 39, wherein thesecond end of each of the plurality of support members is a free end.41. The mask interface of claim 39, wherein each of the plurality ofsupport members curves inwardly such that the second end of each of theplurality of support members is inwardly disposed relative to the firstend.
 42. The mask interface of claim 39, wherein each of the pluralityof support members has a squared-off end at the second end.
 43. The maskinterface of claim 35, wherein each of the plurality of support membersextends partially across the 3-dimensional mask housing.
 44. The maskinterface of claim 35, further comprising a frame comprising a gas inletand being configured to attach to the seal and the 3-dimensional maskhousing so that the gas inlet of the frame substantially forms a fluidflow path with the gas inlet of the seal and the at least one gas inletof the 3-dimensional mask housing.
 45. The mask interface of claim 44,wherein the frame extends around a perimeter of the 3-dimensional maskhousing and each of the plurality of support members is joined to theframe.
 46. The mask interface of claim 44, wherein the plurality ofsupport members is formed from a first material and the frame is formedfrom the first material.
 47. The mask interface of claim 44, wherein theframe connects the 3-dimensional mask housing to the seal.
 48. The maskinterface of claim 35, wherein the seal is formed of silicone.
 49. Themask interface of claim 35, wherein an airtight coating or layer isprovided on an internal surface of the at least one fabric portion ofthe 3-dimensional mask housing.
 50. The mask interface of claim 35,wherein the flexible, resilient support structure of the 3-dimensionalmask housing is configured to at least partially deform under asufficient deforming external force and to substantially return to itsoriginal shape after the sufficient deforming external force is removed.51. The mask interface of claim 35, wherein the flexible, resilientsupport structure is located on an interior surface of the at least onefabric portion of the 3-dimensional mask housing.
 52. The mask interfaceof claim 35, wherein the flexible, resilient support structure comprisesa resilient support layer applied to interior and/or exterior surfacesof the at least one fabric portion of the 3-dimensional mask housing toincrease a thickness of one or more regions of the 3-dimensional maskhousing.
 53. The mask interface of claim 52, wherein the resilientsupport layer is applied near outer edges of the 3-dimensional maskhousing and/or along sides of the 3-dimensional mask housing to increasethe thickness of these regions of the 3-dimensional mask housing. 54.The mask interface of claim 52, wherein the resilient support layercomprises an elastomer.
 55. The mask interface of claim 52, wherein theresilient support layer comprises a vinyl or silicone lining.
 56. Themask interface of claim 35, wherein the flexible, resilient supportstructure comprises a ridge that is provided in the at least one fabricportion of the 3-dimensional mask housing.
 57. The mask interface ofclaim 56, wherein the ridge comprises at least one fold line or seam.58. The mask interface of claim 56, wherein the ridge extends from asubstantially central point at a central region of the 3-dimensionalmask housing to a substantially central point near an upper edge of the3-dimensional mask housing.
 59. A respiratory system comprising: arespiratory mask according to claim 35; a gas delivery tube comprising afirst end configured to connect to the mask interface and a second endconfigured to connect to a gas source; and a CPAP machine.